Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||365 Days - 29 Years|
- - Diagnosis: Relapsed/Refractory neuroblastoma, with an original diagnosis made histologically or from elevated urine catecholamines with abnormal tumor cells in bone marrow OR relapsed/refractory pheochromocytoma.
- - Disease status: Progressive disease at any time (defined as any new lesion or an increase in size by >25% of pre-existing disease), or a failure to respond to standard therapy.
- - Prior therapy: A minimum of two weeks since should have elapsed since any chemotherapy causing myelosuppression.
- - Organ function: ANC >500/uL, platelets >20,000/uL with transfusion allowed.
- - Stem cells: Patients must have a minimum of 2.0 x106/kg viable CD34+ peripheral blood stem cells for re-infusion following 131I-MIBG.
- - Life expectancy longer than 8 weeks,Karnofsky or Lansky performance status of ≥ 50%
Exclusion Criteria:- Pregnant or lactating patients.
- - Disease of any organ system that would compromise the patient's ability to participate in the study, including hemodialysis.
- - Patients with active grade 3-4 infection, as defined by the NCI CTCAE V4.0.
- - Patients with known MBIG-avid brain parenchymal disease (leptomeningeal or skull based metastases are eligible).
- - In patients with metastatic pheochromocytoma, a urinalysis must be preformed prior to study enrollment.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.